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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00561470




Registration number
NCT00561470
Ethics application status
Date submitted
20/11/2007
Date registered
21/11/2007
Date last updated
28/09/2012

Titles & IDs
Public title
Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
Scientific title
A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen
Secondary ID [1] 0 0
EudraCT 2007-000820-42
Secondary ID [2] 0 0
EFC10262
Universal Trial Number (UTN)
Trial acronym
VELOUR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms 0 0
Neoplasm Metastasis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Treatment: Drugs - FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Treatment: Drugs - FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

Placebo comparator: Placebo/FOLFIRI - Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) starting on Day 1 of a 2-week cycle until a treatment discontinuation criterion was met

Experimental: Aflibercept/FOLFIRI - Participants with Metastatic Colorectal Cancer administered Aflibercept followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) starting on Day 1 of a 2-week cycle until a treatment discontinuation criterion was met


Treatment: Drugs: Placebo
4 mg/kg of sterile aqueous buffered vehicle (pH 6.0) was administered intra venously (IV) over 1 hour on Day 1, every 2 weeks

Treatment: Drugs: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.

Treatment: Drugs: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
The FOLFIRI regimen was initiated immediately after Placebo administration on Day 1

The FOLFIRI regimen included:

* 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
* 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
* 5-FU 2400 mg/m² continuous IV infusion over 46-hours

Treatment: Drugs: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
The FOLFIRI regimen was initiated immediately after Aflibercept administration on Day 1

The FOLFIRI regimen included:

* 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
* 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
* 5-FU 2400 mg/m² continuous IV infusion over 46-hours
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)
Secondary outcome [1] 0 0
Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)
Timepoint [1] 0 0
From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)
Secondary outcome [2] 0 0
Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria
Timepoint [2] 0 0
From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)
Secondary outcome [3] 0 0
Number of Participants With Adverse Events (AE)
Timepoint [3] 0 0
From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized
Secondary outcome [4] 0 0
Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay
Timepoint [4] 0 0
Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo

Eligibility
Key inclusion criteria
Participants who met the following main selection criteria were included in the study.



* Histologically or cytologically proven adenocarcinoma of the colon or rectum
* Metastatic disease that is not amenable to potentially curative treatment
* One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible)
* Prior treatment with bevacizumab is permitted.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior therapy with irinotecan
* Eastern Cooperative Oncology Group performance status >2

The above information is not intended to contain all considerations relevant to participation in a clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
1226
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Investigational Site Number 036004 - Hornsby
Recruitment hospital [2] 0 0
Sanofi-Aventis Investigational Site Number 036001 - Kingswood
Recruitment hospital [3] 0 0
Sanofi-Aventis Investigational Site Number 036002 - Kurralta Park
Recruitment hospital [4] 0 0
Sanofi-Aventis Investigational Site Number 036005 - Melbourne
Recruitment hospital [5] 0 0
Sanofi-Aventis Investigational Site Number 036003 - Melbourne
Recruitment hospital [6] 0 0
Sanofi-Aventis Investigational Site Number 036007 - Nedlands
Recruitment hospital [7] 0 0
Sanofi-Aventis Investigational Site Number 036006 - Subiaco
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3050 - Melbourne
Recruitment postcode(s) [5] 0 0
3128 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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California
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maryland
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Michigan
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New Mexico
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Wisconsin
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Argentina
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Bahia Blanca
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Ciudad De Buenos Aires
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Salta
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Wien
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Bonheiden
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Bruxelles
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Odense C
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Ålborg
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France
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Port Elizabeth
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South Africa
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Pretoria
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Barcelona
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Spain
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Madrid
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Reus
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Sweden
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Stockholm
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Sweden
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Sundsvall
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Sweden
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Uppsala
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Turkey
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Adana
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Ankara
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Izmir
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Turkey
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Kayseri
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kharkov
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United Kingdom
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Aberdeen
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United Kingdom
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Bournemouth
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United Kingdom
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Dudley
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Northwood
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
NSABP Foundation Inc
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00561470